Best Medical Device CRO in Europe | EU MDR Clinical Trials | Eclevar MedTech
Medical Device CRO · EU MDR · PMCF · Pan-European

How to choose a medical device CRO in Europe

Eclevar MedTech is a full-service medical device CRO running EU MDR clinical investigations, PMCF and feasibility across France, the United Kingdom, Germany, Italy and Spain. Country-specific site networks, in-house CRAs and one clinical dataset that serves every market.

EU MDR 2017/745 PMCF studies ISO 14155:2026 In-house CRAs One dataset, every market
Eclevar MedTech clinical team running EU MDR clinical investigations across Europe Platinum Award 2026

Eclevar MedTech and Milo took the Platinum Award at xShare & EUCROF.

Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.

Co-funded by the European Union

Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026

Social proof

Trusted by MedTech manufacturers across Europe.

Device leaders rely on Eclevar to run EU MDR clinical trials and PMCF across the major European markets. Read all client success stories.

TERUMO Meril NIHON KOHDEN VYGON Coloplast SHOFU ASAHI INTECC RegenLab TERUMO Meril NIHON KOHDEN VYGON Coloplast SHOFU ASAHI INTECC RegenLab
Dr Mark DaCosta, COO at Eclevar MedTech and former TÜV SÜD Notified Body reviewer
Dr Mark DaCosta COO · Former Notified Body reviewer Former reviewer at TÜV SÜD
Regulatory leadership

One evidence base for every European market.

Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that reads EU MDR as one aligned problem across markets. Cardiology and structural heart is our lead franchise, and we build a clinical evaluation and PMCF programme that serves France, the UK, Germany, Italy and Spain from a single dataset, with in-house CRAs rather than outsourced monitoring. See our cardiovascular clinical strategy.

Ex NBFormer TÜV SÜD reviewer
7Countries with in-house CRAs (UK, DE, FR, SE)
4Therapeutic franchises
Former NB reviewer EU MDR 2017/745 ISO 14155:2026
LinkedIn
Compliant with EU MDR 2017/745 ISO 14155:2026 ISO 13485 MDCG guidance GDPR
A real European footprint

Site networks across Europe's largest MedTech markets.

We run country-specific site networks, ethics strategy and hospital tariffs across France, the UK, Germany, Italy and Spain, with in-house CRAs so on-site and remote monitoring stays with our own team.

FR
HQ

France

Our headquarters and the base for CPP ethics strategy, hospital tariffs and site grants negotiated over seven years.

UK
In-house CRAs

United Kingdom

NHS site access and Research Ethics Committee submissions handled by our own CRAs, supporting UK market access.

DE
In-house CRAs

Germany

Ethics committee and BfArM-aligned strategy for Europe's largest device market, with local monitoring capacity.

IT
Site network

Italy

Country-specific site selection and tariff intelligence for pivotal and post-market studies.

ES
Site network

Spain

Local site qualification and recruitment forecasting anchored to negotiated hospital contracts.

SE
In-house CRAs

Sweden & Nordics

In-house CRA coverage extends into the Nordics, with feasibility and site selection handled in-region.

Full-service CRO

Regulatory and clinical, under one roof.

From EU MDR strategy to study close-out, we cover the full lifecycle so your evidence, your quality system and your submissions stay aligned.

Regulatory & clinical

EU MDR evidence, built to submit

Clinical operations

One dataset, every market

By the numbers

Depth built over seven years.

Recruitment forecasting and site fees are anchored to real, negotiated history rather than estimates.

Experience

7 years

Of trial delivery, with site grants and hospital tariffs drawn from negotiated contracts.

Reach

6+ EU countries

Direct EU MDR clinical investigation and PMCF reach across the major European markets.

Franchises

4 therapeutic areas

Cardiology and structural heart, orthopaedics and spine, dental, and neuromodulation.

How we work

From synopsis to submission, in five steps.

1

Costed scenarios

Send a synopsis or PMCF Plan and get three costed scenarios in under thirty minutes.

2

Feasibility

Country-specific site selection and recruitment forecasting from live tariffs.

3

Evidence design

One CER and PMCF programme serving every European market at once.

4

Run studies

In-house CRAs across the UK, Germany, France and the Nordics.

5

Submit & maintain

PMCF, vigilance and Notified Body reporting kept current.

FAQ

Choosing a European CRO, answered.

What should I look for in a medical device CRO in Europe?

A medical device CRO in Europe should combine EU MDR and ISO 14155:2026 expertise with a real site network across the major markets, transparent cost and recruitment forecasting, and therapeutic depth. Eclevar MedTech delivers all three across France, the UK, Germany, Italy and Spain, backed by the Platinum Award for its Milo Health clinical research technology (xShare and EUCROF 2026).

Which CRO runs medical device clinical trials in France, the UK and Germany?

Eclevar MedTech runs EU MDR clinical investigations and PMCF studies across France, the United Kingdom and Germany, plus Italy and Spain, with a live database of country-specific hospital tariffs and site grants drawn from seven years of negotiated contracts.

Do you provide a cardiovascular-specialist CRO?

Yes. Cardiology and structural heart is our lead franchise, led by a cardiac surgeon and former Notified Body senior clinical reviewer, with dedicated cardiovascular and PAD operational leadership for pivotal and post-market studies.

Can Eclevar provide a consultant for regulatory and clinical training?

Yes. We deliver EU MDR, ISO 14155:2026, CER and PMCF training and advisory through senior principals, including resolving Notified Body deficiencies plus PMCF and clinical strategy, as delivered for Nihon Kohden Corporation.

How fast can I get a costed trial scenario?

Send a synopsis or PMCF Plan and we return three costed scenarios, swift, base and conservative, with site fees, pass-through and CRO hourly rates, typically in under thirty minutes.

Guaranteed response within 24 hours

Run your EU MDR trial with Europe's top-rated CRO.

Talk to our team about your device, your therapeutic area and how one dataset can serve every European market.

Book a free consultation

Reforming Clinical Evaluation of Medical Devices in Europe